Hi,
I would like to know the level of software validation that is required for SCADA/PLC. SCADA is GAMP4 and PLC GAMP 5. What is the validation requirement. Should it be mapped with process validation as well, IQ/OQ/PQ done.
Regards
Amudha
Before process validation occurs, the equipment being used should be fully validated beforehand - no point in validating the process if the equipment the process is based on aren’t working correctly
In your Validation Plan, it should state that process validation cannot occur until the the equipment have been qualified and validated.
The software validation aspect of your validation will depend on the HMI’s of your PLC’s and SCADA’s and how they operate, ie. their functional design.
hope this helps
In a nutshell - validate it too - but perhaps only an IQ and OQ - as the PQ might be adequate from the process side and the test batches etc.
The GAMP V-Model is always a good place to start.
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In more detail (and sorry for repeating anything you already know):
I am assuming you will be doing several risk assessments. I would assume that you probably have “Category 5” software risk (PLC/PAC and SCADA) and then a “Category 2” hardware risk. I don’t think mixing versions of GAMP is a good idea, but then you might be stuck with that.
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Once you have the “5-2” then you just follow GAMP and you’re all done. Coming up the right-hand side of the V-Model you need IQ/OQ and PQ (GAMP4) or equivalent verification documents (GAMP5). As I said, a combined PQ might be adequate as I think the IQ and IQ usually cover off PLC and SCADA. Of course you can save a fair bit of time on the IQ and OQ if you use the supplier documents per GAMP.
RJ
Hi everybody,
My name is Beckson and i’m in a dillema
I have a water system to qualify.whe want to use it quickly, but the problem is that it is equipped with automated signature and electronic data recording system.Whe are installing DELTA V management for all our equipments and this gonna take time to finish and validate.
Question one
Can I at the first time qualify the water system without following 21 CFR part 11 recommendation and do another requalification as soonas the delta V system is installed and validated?
Question 2
Can I take as reference test done in the SAT during this month?
Thank every body
[quote=beckson]Question one
Can I at the first time qualify the water system without following 21 CFR part 11 recommendation and do another requalification as soonas the delta V system is installed and validated? [/quote]
Can you? Yes. Would you be exposed to regulatory repercussions? Yes!
Instead of sweeping it under the rug, though, do a risk analysis (documented) on what not being validated for ER/ES might result in and (likely) take some precautions (e.g., print out paperwork temporarily).
[quote=beckson]Question 2
Can I take as reference test done in the SAT during this month?[/quote]
Depends on several things. Did the SAT fully verify the system (demonstrated with objective evidence that all requirements were met)? Was the SAT done in a production environment? Do you have procedures (e.g., a Validation Master Plan or Validation SOP) that would disqualify SAT results from being used?
GAMP4 is replaced by GAMP2